NDA Submitted for Crizotinib for NSCLC
Pfizer announced that its New Drug Application (NDA) for crizotinib, an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted priority review status by the FDA. The FDA's priority review status of crizotinib accelerates the review time to six months.
Crizotinib is an investigational oral first-in-class compound that inhibits ALK. Alterations in the ALK gene are believed to be a key driver of tumor development in cancers such as NSCLC. Preliminary data suggests that approximately 3–5% of NSCLC patients have tumors that are positive for the ALK fusion gene. By inhibiting ALK, crizotinib blocks signaling pathways that are critical for the growth and survival of tumor cells.
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